Freelance Process Validation Engineer


Galway
Contract
Negotiable
Quality
CR/545350_1747299932
Freelance Process Validation Engineer

Project Overview:

Join a high-impact containment upgrade project focused on granulation suites within a solid oral dosage manufacturing facility. This is a key role within a multidisciplinary team, supporting critical validation activities from equipment qualification through to final documentation.

Key Responsibilities:

  • Develop and execute IQ, OQ, and PQ protocols in line with GMP and regulatory requirements.
  • Support the installation and qualification of upgraded containment equipment within granulation processes.
  • Interface with engineering, production, and QA teams to ensure seamless execution of validation deliverables.
  • Author and review validation reports, risk assessments, and deviation documentation.
  • Drive issue resolution and ensure validation milestones are met according to project timelines.

Required Experience:

  • 3+ years' experience in validation engineering within pharmaceutical manufacturing (not laboratory-based).
  • Strong understanding of solid oral dosage forms, particularly granulation, blending, and tableting processes.
  • Proven ability to write and execute IQ/OQ/PQ documentation.
  • Familiarity with containment systems and GMP standards in a manufacturing environment.

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